Registration Dossier

Administrative data

Description of key information

Skin irritation, rabbits  (OECD TG  404):   irritating (90% retinyl propionate)
Skin irritation, rabbits (OECD TG 405): slightly irritating (50% retinol)

Key value for chemical safety assessment

Additional information

Skin irritation:

No valid in vivo data are available for retinol on skin irritation.

In an in vitro sceening study (EpiDerm), cis- and trans-retinol up to a concentration of 25% showed no or a slight decrease in cell viability (approx. 80% of respective controls) after a 1 hour incubation (BASF 62H0158/992065, 62H0159/992087). The observed ET50 values  (the effective time resulting in a 50% reduction  of cell viability) were 1088 -1303 minutes. The findings obtained provide evidence for an absence of a corrosive potential of retinol.

The key study for skin irritation was performed according to GLP and OECD guideline 404, using New Zealand White Rabbits and the structural analogue retinyl propionate (purity approx. 90%; DSM B-154´448).

Reversible erythema and edema was observed. Individual erythema mean scores (24 -72 hrs) were >=2 (but <2.3 in 2/3 animals) and reversible desquamation or scabbing, epidermal lesions and scaling was observed in 3/3 animals. Therefore retinyl propionate was identified to be irritating to the skin.

Eye irritation:

As key study, a technical preparation of retinol (Retinol 50C, containing approx. 50% retinol) has been tested in an eye irritation study according to OECD guideline 405, and GLP in New Zealand white rabbits (BASF 11H0097/992318).The test material showed a slight and reversible eye irritation potential under the conditions of this study.  The mean score (24 -72 hours and all animals tested) was 0.0 for corneal opacity and for iris; 2.3 for conjunctival redness; and 1.4 for chemosis.  All findings observed were fully reversible within 7 days. No eye irritation potential has been observed in structurally analogous substances , i.e. retinyl propionate and retinyl palmitate.

An in vitro screening study, i.e. the HET-CAM test with cis-/trans-retinol, provides evidence for the absence of a serious eye damage potential of the tested substances (BASF 60H0158/992064; 60H0159/992088).

Effect level: empty Endpoint conclusion: Adverse effect observed

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin irritation:

The present data fulfill the criteria laid down in 67/548/EEC and a classification "irritating to skin" (R38) is warranted. According to 1272/2008/EEC, a non-classification is warranted. According to UN-GHS, the test substance needs to be classified "skin irritant" (category 3).

Eye irritation:

The present data on eye irritation do not fulfill the criteria laid down in 67/548/EEC. According to 1272/2008/EEC, a classification as "irritating to eyes" (Category 2) is warranted. According to UN-GHS, a classification as " mildly irritating to eyes" (Category 2B) is warranted.